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| Product NDC Code | 84792-120 | ||||
|---|---|---|---|---|---|
| Drug Name | Fresh monster mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Blue Zebra Brands, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Water, Coco-Caprylate, Dicaprylyl Carbonate, Glycerin, Microcrystalline Cellulose, Lauryl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis (Marigold) Flower Extract*, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Caprylate, Phytic Acid, Cellulose Gum, Xanthan Gum, Polyhydroxystearic Acid, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil*, Diheptyl Succinate, Triethoxycaprylylsilane, Glyceryl Isostearate, Glyceryl Stearate, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid. *Certified Organic Ingredients
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am -2pm wear long-sleeved shirt, pants, hats and sunglasses Children under 6 months of age: Ask a doctor
Spl product data elements
Usually a list of ingredients in a drug product.Fresh Monster Mineral Sunscreen Zinc Oxide COCO-CAPRYLATE ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Non-Nano Uncoated Zinc Oxide 20.0% Active Ingredient
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS For External Use Only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API